What are the FDA requirements for food

FDA requirements for Food explained
FDA Requirements for Food Products

FDA requirements for food

1. Food Facility Registration

Food facility registration is one of the  FDA requirements for food products.

If you are a foreign company or importing food products manufactured in foreign country, then such foreign facilities are required to appoint U.S Agent and register the facility.  Pragmatic Compliance LLC shall act as U.S Agent for food facility registration purpose and register the facility. Our fee for food facility registration including one-year U.S Agent services is $ 299.

You can complete our online food facility registration form  below link and make the payment. It will take less than two working days to obtain food facility registration number. 

If you are domestic food manufacturing, processing, packing or warehouse facility, you are required to register with FDA. Our fee for domestic food facility registration is $ 149. Please contact us for offline form.

Please note, FDA does not issue the food facility certificate and certificate is not required. You will get the food facility registration number from FDA through email.  Our company can issue the food facility registration certificate for your reference.

2.Labeling Compliance   

Product   labeling is one of the  most important FDA requirement for food products.

Labeling is one of the important FDA requirements for food products.  We can offer labelling review services and our fee for per product labelling review is $ 299. In order to review the label, you should provide us label design in PDF or image format. 

We offer discount on multiple labeling review.

Failure to comply with labeling requirements may result in a misbranded product and detention action.

3.Prior Import notice 

Before shipping goods, you must notify FDA about arrival of your shipments well in advance by submitting prior import notice.

If you wish to file prior import notice yourself, we can send you the step by step instruction which you can follow and submit the prior import notice. If you want us to submit prior import notice, then our fee for per shipment prior notice filing is $ 15. 

4.FSVP Agent or Importer

Foreign manufacturer is required to identify the importer for FSMA compliance purpose. If you are importer or already have importer in the United  States, such importer is responsible for supplier verification responsibilities.

Pragmatic compliance can act as FSVP importer for foreign companies, fee for  FSVP Agent services depends on the Product and projected  annual sales in terms of USD.

Foreign manufacturer has to  go through our supplier evaluation process and we may  require several product quality and safety related documents in order to act as FSVP Agent.  Please contact us for more information.

5.  Good Manufacturing Practice and HACCP

GMP and  HAACP are  most important  FDA requirement for food manufacturer.

In order to food and dietary supplements in the United States companies should follow GMP and maintain proper documentation. After the facility is registered you can start shipping the products however FDA may visit your facility at time.

Additional requirements Low Acid or Acidified Products

All commercial processors of low-acid and acidified foods located in the United States and all processors in other countries who export low-acid canned food or acidified food products into the United States must register their processing plants with FDA. Wholesalers, importers, distributors, brokers, etc. are not required to register and file processes. However, they must ensure that processing firms they represent comply with all registration and process filing requirements.

Note: – If you are low acid or canned food manufacturer please contact us for more information.

We can assist you to  comply with all applicable FDA requirements for food products. 

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